Combining Topical Imiquimod With Local Radiotherapy for Treatment of Mycosis Fungoides

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT05838599
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Mycosis Fungoides

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Imiquimod — DRUG
    5% cream applied topically 5 days/week for 6 weeks
  • Radiation Therapy — RADIATION
    2 fractions of 4 Gys (total of 8 Gys) starting 1 week after Imiquimoid course over 2 days.

Study Details

Mycosis fungoides (MF) is the most common subtype of cutaneous T cell lymphoma (MF) and presents as cutaneous patches, plaques, and tumors. Radiation therapy (RT) is a frequently pursued management option for CTCL, especially in patients with more advanced skin disease. Imiquimod stimulates a Th1 lymphocyte response with increased IL-2 and IFN-α, but also induces IFN-α, TNF-α, IL-1α, IL-6, and IL-8, thereby bridging both innate and adaptive immunity. Dosing of both radiotherapy (RT) and imiquimod are based on standard-of-care doses/frequencies for CTCL. The reason imiquimod topical is given for a week before giving RT is to prime innate immune activity for when RT is delivered. It is believed that this serves as an adjuvant for the CD8+ antitumor response generated by RT. The primary aim of this study is to assess the safety and efficacy of a combination local radiotherapy and topical imiquimod approach for the treatment of conventional (CD4+) MF.

Key Dates

Start date
Jul 24, 2023
Status verified
Apr 2026
Primary completion
Jun 1, 2027
Completion
Dec 1, 2027

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Topical IMQ and localized RT
    After the initial study visit, patients will immediately begin use of imiquimod cream at designated lesions (those with combined size \>50cm2) nightly for 5 consecutive days a week over 6 weeks. One week into the imiquimod treatment course, radiation therapy will be administered at Northwestern Medicine by radiation oncologists familiar with MF in 2 fractions of 4 Gy (total 8 Gy) over 2 days to the same designated lesions.

Primary Outcome Measure

Efficacy of a combination local radiotherapy and topical imiquimod approach for the treatment of conventional (CD4+) MF as measured by mSWAT at week 8. [ Time Frame: 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern University Department of DermatologyChicagoIllinois60611
Dermatology CTU

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Northwestern University Department of Dermatology· Chicago, IL

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